BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM

    MDR report key: 4804112 · Received May 29, 2015

    Report

    Report Number
    1119421-2015-05476
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    May 6, 2015
    Report Date
    August 26, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A PATIENT EXPERIENCED TASS SYNDROME THE FOLLOWING DAY OF A CATARACT SURGERY. THE AFFECTED EYE WAS THE LEFT ONE. THE PATIENT HAD NO PAIN AND HIS EYE WAS WHITE. CORTICOIDS WERE USED TO TREAT THE EVENT AND THE PATIENT WAS RECOVERING. IT IS UNKNOWN WHICH BSS BAG LOT NR .WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS ONE OF FOUR REPORTS BEING FILED FOR THE SAME FACILITY. THIS REPORT IS FOR THE FIRST PATIENT AND FOR THE IOL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY A COMPANY REPRESENTATIVE CLARIFIED THAT THE SYSTEM WAS NOT A SUSPECT. ACCORDING TO THE HOSPITAL STAFF, A FAILURE IN THE CLEANING AND PLASMA GAS MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, THE FACILITY WANTED TO CONFIRM THAT THE SURGICAL SOLUTION AND THE INTRAOCULAR LENS HAD NO ISSUES IN THEIR MANUFACTURING PROCESS. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349205 ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB ALCON RESEARCH, LTD. - HUNTINGTON SN6CWS 12325882

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other CENTURION VISON SYSTEM| BSS 500ML| MAXIDEX| VIGAMOX (PRE-SURGERY)